Common use of Manufacture Clause in Contracts

Manufacture. Without limiting Genentech’s other rights and obligations under this Part 2 of Schedule D, if Genentech is Manufacturing an Active Product on the effective date of termination, it shall continue to comply with its obligations to Manufacture the applicable Active Product under Article 10 herein and the Manufacturing and Supply Agreement(s), unless it provides written notice to Novartis that it does not intend to continue to Manufacture and supply to Novartis such Active Product. In the event that Genentech provides such notice to Novartis, Genentech will supply Novartis with Clinical Requirements and Commercial Requirements of such finished and packaged Active Product(s) at the same price and other terms and conditions as Genentech was supplying, or in the absence of termination, would have been required to supply of such finished and packaged Active Product (under Article 10 hereof), until ***** the date of Novartis’ receipt of such notice, and, if Novartis so requests no more than ***** after the date it received such notice, for *****, provided that the price at which such Active Products will be supplied for such ***** and other terms and conditions on which such Active Products will be supplied for ***** shall be reasonable and customary as determined by good faith negotiations between the Parties, provided further that such ***** is subject to the reasonable cooperation of Genentech. Notwithstanding the foregoing, in no event shall Genentech be obligated to Manufacture a higher volume of Active Product than (i) the reserved manufacturing capacity in the manufacturing facility(ies) of Genentech, its Affiliate(s) or sublicense(s) as set forth in the Manufacturing and Supply Plan, with respect to the ***** of the transition period, and (ii) the average of such manufacturing capacity reserved for the ***** of the transition period, with respect to the ***** of the transition period. Subject to the foregoing, Genentech’s obligations under Section 10.3 of this Agreement, the Manufacturing and Supply Agreement and Sections 5.2(a) and 5.2(c) of the JCA and all other related provisions (if any) under the Ancillary Agreements shall terminate. The applicable Manufacturing and Supply Agreement shall terminate at the end of such ***** period, as applicable.

Manufacture. Without limiting Genentech’s other rights (a) During the Term and obligations under subject to this Part 2 of Schedule D, if Genentech is Manufacturing an Active Product Section 3.4. CDI (and its Affiliates) shall have the exclusive right to manufacture and supply iPSC to Century for [***] beginning on the effective date Effective Date. If at any time following [***] of terminationthe Effective Date, it shall continue Century wishes to comply with its obligations to Manufacture the applicable Active Product under Article 10 herein and the Manufacturing and Supply Agreement(shave a Third Party manufacture human iPSC (including TiPSC), unless it provides written notice Century shall discuss with CDI in good faith the possibility of using such Third Party to Novartis manufacture human iPSC (including TiPSC), provided that it does not intend Century shall have the sole discretion to continue determine whether to Manufacture and supply to Novartis use CDI or such Active ProductThird Party for such manufacture of iPSC (including TiPSC). In the event that Genentech provides such notice Century elects to Novartisuse a Third Party manufacturer, Genentech will supply Novartis CDI hereby agrees to amend the terms of this Agreement without delay to provide Century, its Affiliates and Sublicensees with Clinical Requirements and Commercial Requirements the necessary licenses under the Licensed Patent Rights for the Exploitation of such finished products, including amending the definition of “Licensed Product” to remove the limitation that iPSC be exclusive manufactured by CDI. The Parties shall negotiate in good faith as soon as reasonably practical the terms of a manufacturing and packaged Active Product(ssupply agreement under which CDI or its Affiliate would itself manufacture and supply iPSC (a “Supply Agreement”) at and the same price terms of a quality agreement which would provide the responsibilities of Century and other CDI or its Affiliates for quality assurance of human iPSC (including TiPSC) and the Licensed Products referenced in the Supply Agreement (a “Quality Agreement”). (b) The Supply Agreement and Quality Agreement shall each contain terms and conditions as Genentech was supplying, or in that are commercially reasonable given the absence terms of termination, would have been required to supply of such finished and packaged Active Product (under Article 10 hereof), until ***** the date of Novartis’ receipt of such notice, and, if Novartis so requests no more than ***** after the date it received such notice, for *****, provided that the price at which such Active Products will be supplied for such ***** and other terms and conditions on which such Active Products will be supplied for ***** shall be reasonable and customary as determined by good faith negotiations between the Parties’ collaboration under this Agreement, provided further including manufacturing capacity, quantity, forecasting, timeliness of delivery, quality, cost, and failure of supply that such ***** is subject to the reasonable cooperation of Genentech. Notwithstanding the foregoing, in no event are consistent with prevailing industry standards for Third Party contract manufacturing agreements for comparable products. (c) The Supply Agreement shall Genentech be obligated to Manufacture a higher volume of Active Product than provide: (i) the reserved manufacturing capacity in the manufacturing facility(iesCDI’s (and its Affiliates) of Genentech, exclusive right to manufacture and supply human iPSC (including TiPSC) to Century and its Affiliate(s) or sublicense(s) as set forth in the Manufacturing and Supply Plan, with respect to the ***** of the transition period, and Sublicensees: (ii) CDI’s (and its Affiliates or contractors) obligations to perform manufacturing activities in a good scientific manner and in compliance in all material respects with all applicable Law; and (iii) Century’s ability to manufacture by itself or through its Affiliate, or to grant to a Third Party manufacturer the average of such manufacturing capacity reserved for the ***** of the transition period, with respect right to the ***** of the transition period. Subject to the foregoing, Genentech’s obligations under Section 10.3 of this Agreementmanufacture, the Manufacturing and Supply Agreement and Sections 5.2(a) and 5.2(c) Licensed Products in minimal quantities necessary to prevent a supply interruption in the event of the JCA and all other related provisions (if any) under the Ancillary Agreements shall terminate. The applicable Manufacturing and Supply Agreement shall terminate at the end of such ***** period, as applicablea non-supply event upon Century’s request.

Manufacture. Without limiting Genentech’s other rights 6.1. The final sentence of Clause 11.1 of the Original Agreement is hereby amended by replacing the references to “Clause 11.3” in each case with the phrase “Clause 11.3 or Clause 11.6”. 6.2. Clause 11.2 of the Original Agreement is hereby amended by deleting the clause following Clause 11.2.2 and obligations under replacing it with the following text: “ and where this Part 2 of Schedule D, if Genentech is Manufacturing an Active Product on the effective date of termination, it Clause 11.2 applies Licensor shall continue to comply with its obligations to Manufacture the applicable Active supply Product under Article 10 herein and the Manufacturing and Supply Agreement(s)terms of this Agreement, unless it provides and until such Second Source has been validated and has commenced and scaled up manufacture to satisfy the requirements for Product of Licensee. Licensee shall provide Licensor with written notice no later than [*] ([*]) Business Days after the Second Source has been validated and has commenced and scaled up manufacture to Novartis that it does not intend to continue to Manufacture and supply to Novartis such Active Product. In satisfy the event that Genentech provides such requirements for Product of Licensee, following which notice to Novartis(or, Genentech will supply Novartis with Clinical Requirements and Commercial Requirements of such finished and packaged Active Product(s) at the same price and other terms and conditions as Genentech was supplying, or in the absence of termination, would have been required to supply of such finished and packaged Active Product (under Article 10 hereof), until ***** the date of Novartis’ receipt of such notice, and, if Novartis so requests no more than ***** after the date it received such notice, for *****, provided that the price at which such Active Products will be supplied for such ***** and other terms and conditions on which such Active Products will be supplied for notice ought to have been given) Licensor shall have the option (but not the obligation) at any time thereafter upon service of not less than [*] ([*]) days notice in writing to cease to supply Product to Licensee. Licensee shall use Commercially Reasonable Efforts to cause Novel to qualify, validate and scale up manufacture, and Actavis to supply, by [*** shall be reasonable and customary as determined by good faith negotiations between ]. For the Partiesavoidance of doubt, provided further that such ***** is subject to the reasonable cooperation of Genentech. Notwithstanding the foregoing, in no event shall Genentech be obligated to Manufacture a higher volume of Active Product than Licensor (i) hereby expressly consents to and acknowledges the reserved manufacturing capacity appointment by Licensee pursuant to this Clause 11.2 of Novel as the Second Source and of Novel and Actavis as Licensee’s sub-contractors and to the terms of the Supply Agreement (excluding those provisions of the Supply Agreement that have been redacted in the manufacturing facility(ies) of Genentechversion supplied to Licensor), its Affiliate(s) or sublicense(s) as set forth provided that, notwithstanding any provisions in the Manufacturing Supply Agreement, Licensee shall have the right to select and Supply Plan, use a Second Source other than Novel only in accordance with respect to the ***** of the transition periodthis Clause 11, and (ii) agrees to comply with the average provisions of such manufacturing capacity reserved this Clause 11 relating to assistance with technology transfer and the obtaining of Regulatory Approvals necessary for Novel to act as Second Source, and agrees to do so on a reasonably timely and expeditious basis so as to facilitate and enable the qualification, validation and scale up of Novel as Second Source by [*], or as soon thereafter as possible, but in any event by [**** ]. For avoidance of doubt, (i) no consent is granted by Licensor to any amendment to or waiver of the transition periodSupply Agreement, except as may be subsequently provided by Licensor in a written agreement with respect to the ***** Licensee; (ii) Novel and Actavis shall be deemed Licensee’s sub-contractors, and not Licensor’s sub-contractors, for purposes of the transition period. Subject to the foregoingthis Agreement and, Genentechwithout limiting or qualifying Licensor’s obligations under Section 10.3 of this Agreement, the Manufacturing and Supply Agreement and Sections 5.2(a) and 5.2(cpursuant to clause (ii) of the JCA preceding sentence, as between Licensor and all other related provisions Licensee, Licensee shall be responsible for arranging and coordinating the technology transfer to Novel and for obtaining any Regulatory Approvals necessary for Novel to act as a Second Source and Actavis to supply Product; and (if anyiii) without limiting Licensor’s obligation to comply with this Clause 11, Licensor makes no representations, warranties or promises that Novel will be qualified, validated or commence and scale up manufacture, or that Actavis will commence supply, to satisfy the requirements of Licensee for Product.” 6.3. Clause 11.4.2 of the Original Agreement is hereby amended to read in its entirety as follows: “All Product and Authorized Generic Product shall be manufactured in the manner specified in the Initial NDA and in accordance with GMP and the Specifications and the Packaging and Labelling for any Product or Authorized Generic Product shall accurately identify Licensee or the Second Source as the manufacturer of such Product or Authorized Generic Product, as the case may be;” 6.4. Clause 11.4.4 of the Original Agreement is hereby amended by deleting the term “NDA” and replacing it with the term “Initial NDA”. 6.5. Clause 11.5 of the Original Agreement is hereby amended to read in its entirety as follows: “Without limiting Licensor’s right to cease supply of Product under Clause 11.2, from and after [*], Licensor shall have the Ancillary Agreements shall terminate. The applicable Manufacturing and Supply Agreement shall terminate option (but no obligation) upon service of not less than [*] ([*]) months notice in writing, to expire at the end of a Year, to cease to supply Product to Licensee, under the terms of this Agreement.” 6.6. Clause 11 of the Original Agreement is hereby amended by adding a new Clause 11.6 and a new Clause 11.7 at the end thereof, such ***** period, new clauses to read as applicable.follows:

Manufacture. Without limiting Genentech’s the other rights and obligations of the Terminating Party(ies) under this Part 2 1 of Schedule D, if Genentech each Terminating Party that is Manufacturing an Active Product on the effective date of termination, it termination with respect to such Terminating Party(ies) shall continue to comply with its obligations to Manufacture the applicable Active Product under Article 10 herein and the Manufacturing and Supply Agreement(s), unless it provides written notice to Novartis Tanox that it does not intend to continue to Manufacture and supply to Novartis Tanox such Active Product. In the event that Genentech After such Terminating Party(ies) provides such notice to NovartisTanox, Genentech such Terminating Party(ies) will supply Novartis Tanox with Clinical Requirements and Commercial Requirements of such finished and packaged Active Product(s) at the same price and other terms and conditions as Genentech the Terminating Party(ies) was supplying, or in the absence of termination, would have been required to supply of such finished and packaged Active Product (under Article 10 hereof), until ***** of the date of Novartis’ Tanox’s receipt of such notice, and, if Novartis Tanox so requests no more than ***** after the date it received such notice, for *****, provided that the price at which such Active Products will be supplied for such ***** and other terms and conditions on which such Active Products will be supplied for ***** shall be reasonable and customary as determined by good faith negotiations between the Parties, provided further that such ***** is subject to the reasonable cooperation of Genentechthe Manufacturing Party. Notwithstanding the foregoing, in no event shall Genentech a Terminating Party be obligated to Manufacture a higher volume of Active Product than (iA) the reserved manufacturing Manufacturing capacity in the manufacturing Manufacturing facility(ies) of Genentechthe Terminating Party, or its Affiliate(s) or sublicense(s) sublicensee(s), as set forth in the Manufacturing and Supply PlanPlan or other equivalent three year Manufacturing plan, with respect to the ***** of the transition period, and (iiB) the average of such manufacturing Manufacturing capacity reserved for the ***** of the transition period, with respect to the ***** of the transition period. Subject to the foregoing, Genentech’s obligations under the Manufacturing and Supply Agreement, and the Terminating Party’s obligations under Section 10.3 of this Agreement, the Manufacturing and Supply Agreement and Sections 5.2(a) and 5.2(c) of the JCA and all other related provisions (if any) under the Ancillary Agreements shall terminate. The applicable Manufacturing and Supply Agreement shall terminate at the end of such ***** period, as applicable.

Manufacture. Without limiting Genentech’s the other rights and obligations of the Terminating Party(ies) under this Part 2 1 of Schedule D, if Genentech each Terminating Party that is Manufacturing an Active Product on the effective date of termination, it termination with respect to such Terminating Party(ies) shall continue to comply with its obligations to Manufacture the applicable Active Product under Article 10 herein and the Manufacturing and Supply Agreement(s), unless it provides written notice to Novartis Tanox that it does not intend to continue to Manufacture and supply to Novartis Tanox such Active Product. In the event that Genentech After such Terminating Party(ies) provides such notice to NovartisTanox, Genentech such Terminating Party(ies) will supply Novartis Tanox with Clinical Requirements and Commercial Requirements of such finished and packaged Active Product(s) at the same price and other terms SCHEDULE D and conditions as Genentech the Terminating Party(ies) was supplying, or in the absence of termination, would have been required to supply of such finished and packaged Active Product (under Article 10 hereof), until ***** of the date of Novartis’ Tanox’s receipt of such notice, and, if Novartis Tanox so requests no more than ***** after the date it received such notice, for *****, provided that the price at which such Active Products will be supplied for such ***** and other terms and conditions on which such Active Products will be supplied for ***** shall be reasonable and customary as determined by good faith negotiations between the Parties, provided further that such ***** is subject to the reasonable cooperation of Genentechthe Manufacturing Party. Notwithstanding the foregoing, in no event shall Genentech a Terminating Party be obligated to Manufacture a higher volume of Active Product than (iA) the reserved manufacturing Manufacturing capacity in the manufacturing Manufacturing facility(ies) of Genentechthe Terminating Party, or its Affiliate(s) or sublicense(s) sublicensee(s), as set forth in the Manufacturing and Supply PlanPlan or other equivalent three year Manufacturing plan, with respect to the ***** of the transition period, and (iiB) the average of such manufacturing Manufacturing capacity reserved for the ***** of the transition period, with respect to the ***** of the transition period. Subject to the foregoing, Genentech’s obligations under the Manufacturing and Supply Agreement, and the Terminating Party’s obligations under Section 10.3 of this Agreement, the Manufacturing and Supply Agreement and Sections 5.2(a) and 5.2(c) of the JCA and all other related provisions (if any) under the Ancillary Agreements shall terminate. The applicable Manufacturing and Supply Agreement shall terminate at the end of such ***** period, as applicable.

Manufacture. Without limiting Genentech’s Novartis’ other rights and obligations under this Part 2 3 of Schedule D, if Genentech Novartis is Manufacturing an Active Product on the effective date of termination, it shall continue to comply with its obligations to Manufacture the applicable Active Product under Article 10 herein and the Manufacturing and Supply Agreement(s), unless it provides written notice to Novartis Genentech and Tanox that it does not intend to continue to Manufacture and supply to Novartis such Active Product. In the event that Genentech Novartis provides such notice to NovartisGenentech and Tanox, Genentech Novartis will supply Novartis Genentech and Tanox with Clinical Requirements and Commercial Requirements of such finished and packaged Active Product(s) at the same price and other terms and conditions as Genentech Novartis was supplying, or in the absence of termination, would have been required to supply of such finished and packaged Active Product (under Article 10 hereof), until ***** the date of Novartis’ Genentech’s and Tanox’s receipt of such notice, and, if Novartis Genentech and Tanox both so requests request no more than ***** after the date it received such notice, for *****, provided that the price at which such Active Products will be supplied for such ***** and other terms and conditions on which such Active Products will be supplied for ***** shall be reasonable and customary as determined by good faith negotiations between the Parties, provided further that such ***** is subject to the reasonable cooperation of GenentechNovartis. Notwithstanding the foregoing, in no event shall Genentech Novartis be obligated to Manufacture a higher volume of Active Product than (i) the reserved manufacturing capacity in the manufacturing facility(ies) of GenentechNovartis, its Affiliate(s) or sublicense(s) as set forth in the Manufacturing and Supply Plan, with respect to the ***** of the transition period, and (ii) the average of such manufacturing capacity reserved for the ***** of the transition period, with respect to the ***** of the transition period. Subject to the foregoing, Genentech’s Novartis’ obligations under Section 10.3 of this Agreement, the Manufacturing and Supply Agreement and Sections 5.2(a) and 5.2(c) of the JCA and all other related provisions (if any) under the Ancillary Agreements shall terminate. The applicable Manufacturing and Supply Agreement shall terminate at the end of such ***** period, as applicable.

Manufacture. Without limiting Genentech’s other rights (a) Nektar shall Manufacture the Product, and prior to shipment to Amgen, store at the Facility, Release and Deliver the Product, as specified in Orders, all in compliance with the terms of this Supply Agreement including without limitation the terms of the Quality Agreement. Nektar shall meet the Standard of Care in the performance of its obligations under this Part 2 Supply Agreement. Nektar shall provide all that is required or necessary to perform its obligations under this Supply Agreement including without limitation providing all permits, licenses, authorizations, registrations, labor, supervision, facilities, machinery, equipment, materials (including without limitation Raw Materials), supplies, intellectual property rights, maintenance, calibration, validation and resources. Nektar has submitted to Amgen, and Amgen has approved in writing concurrently with entering into this Supply Agreement, copies of Schedule Dthe Manufacturing Documents. (b) Subject to the provisions of this Section 4.1, including without limitation the provisions governing Agreed Improvements and Agreed Change Costs, Amgen shall have the right, in its reasonable discretion, to make changes to any of the Amgen-Approved Manufacturing Documents and Specifications. Amgen shall submit to Nektar a Change Notification with respect to [***] that, on the Effective Date, is set forth in the Specification on Appendix G to the Quality Agreement. No later than [***] after Nektar’s receipt of each Change Notification or such longer period as specified, or agreed to (such agreement not to be unreasonably withheld or delayed), in writing by Amgen, Nektar shall revise pursuant to the Change Notification the documents that are the subject to the Change Notification and submit such revised documents to Amgen for review and approval. Concurrently and in addition, Nektar shall notify Amgen (each a “Response Notice”) of (i) any Proposed Improvements (including the schedule for undertaking and completing any Proposed Improvements which schedule may take into consideration Nektar’s other manufacturing activities at the Facility to the extent that implementation of the Proposed Improvements would result in [***] interruption of or interference with such other activities) and Proposed Change Costs and (ii) any and all intellectual property rights of Third Parties of which Nektar has knowledge that might be relevant to the Change Notification. Unless Amgen specifies or agrees in writing to a longer period, within [***] after Amgen’s receipt of each timely submitted Response Notice (the “Response Notice Review Period”), in good faith, the Parties shall discuss the Proposed Improvements and Proposed Change Costs and attempt to reach agreement on the scope and schedule of the Proposed Improvements and the Proposed Change Costs to be reimbursed to Nektar by Amgen (the aspects of the Proposed Improvements and Proposed Change Costs, and any modifications thereto, agreed in writing by the Parties shall be referred to as, respectively, the “Agreed Improvements” and “Agreed Change Costs”). With respect to each Response Notice submitted pursuant to this Section 4.1(b) on which the Parties do not reach agreement as to the scope of the Proposed Improvements or the Proposed Changes Costs to be reimbursed to Nektar by Amgen before the end of the Response Notice Review Period, a Party may escalate the review of such Response Notice and the associated Change Notification pursuant to the escalation process set forth in Section 12.18 and, if Genentech the Parties do not reach agreement as part of such escalation, then the Parties shall refer the matter to an independent Third Party with expertise in manufacturing facility operation and mutually agreed upon by the Parties, such agreement not to be unreasonably withheld or delayed (“Manufacturing Change Evaluator”). Within [***] after referral to the Manufacturing Change Evaluator, Amgen shall submit to the Manufacturing Change Evaluator the Change Notification and Response Notice, and Amgen shall cause the Manufacturing Change Evaluator to determine the scope of the Proposed Improvements and the Proposed Change Costs to be reimbursed to Nektar by Amgen. Unless Amgen withdraws or modifies the Change Notification that is the subject of the evaluation of the Manufacturing an Active Product Change Evaluator, the determination of the Manufacturing Change Evaluator shall be binding on the effective date Parties. The determination of terminationthe Manufacturing Change Evaluator shall be deemed Confidential Information hereunder. The fees and expenses of the Manufacturing Change Evaluator shall be borne by [***]. Amgen may at any time, it by notice to Nektar, withdraw or modify any Change Notification, and if Amgen withdraws a Change Notification that is subject to review by a Manufacturing Change Evaluator before such evaluator makes a determination, then Amgen shall continue pay the fees and expenses of such Manufacturing Change Evaluator. With respect to changes to the Manufacturing Documents and the implementation thereof and changes to the Specifications, Amgen shall only be obligated to reimburse Nektar for the Agreed Change Costs and, to the extent consented to in writing and in advance by Amgen, such consent not to be unreasonably withheld, the actual costs incurred by Nektar to secure intellectual property rights from Third Parties. (c) After approval by Amgen and, as applicable and pursuant to Section 4.1(b), after establishing the Agreed Improvements and Agreed Change Costs, Nektar shall do all that is necessary or required to comply with its obligations to Manufacture the applicable Active Product under Article 10 herein Amgen-Approved Manufacturing Documents. Duplicate originals of the most current Amgen-Approved Manufacturing Documents shall be maintained by each Party and the Manufacturing and shall be automatically incorporated into this Supply Agreement(s), unless it provides written notice to Novartis that it does not intend to continue to Manufacture and supply to Novartis such Active ProductAgreement by reference. In Manufacturing the event that Genentech provides such notice to NovartisProduct, Genentech will supply Novartis Nektar shall comply in all respects with Clinical Requirements and Commercial Requirements of such finished and packaged Active Product(s) at the same price and most current Amgen-Approved Manufacturing Documents along with all other terms and conditions of this Supply Agreement. (d) After Nektar’s receipt of each Change Notification related to the Specifications and after establishing, as Genentech was supplying, or in the absence of termination, would have been required applicable and pursuant to supply of such finished and packaged Active Product (under Article 10 hereofSection 4.1(b), until ***** the date of Novartis’ receipt of Agreed Change Costs and Agreed Improvements, each such notice, and, if Novartis so requests no more than ***** after the date it received such notice, for *****, provided that the price at which such Active Products will be supplied for such ***** and other terms and conditions on which such Active Products will be supplied for ***** changed Specification shall be reasonable and customary as determined by good faith negotiations between the Parties, provided further that such ***** is subject to the reasonable cooperation of Genentech. Notwithstanding the foregoing, in no event shall Genentech be obligated to Manufacture a higher volume of Active Product than (i) the reserved manufacturing capacity in the manufacturing facility(ies) of Genentech, its Affiliate(s) or sublicense(s) as set forth in the Manufacturing and Supply Plan, with respect to the ***** of the transition period, and (ii) the average of such manufacturing capacity reserved for the ***** of the transition period, with respect to the ***** of the transition period. Subject to the foregoing, Genentech’s obligations under Section 10.3 of automatically incorporated into this Agreement, the Manufacturing and Supply Agreement and Sections 5.2(a) and 5.2(c) of the JCA and all other related provisions (if any) under the Ancillary Agreements shall terminate. The applicable Manufacturing and Supply Agreement shall terminate at the end of such ***** period, as applicableby reference.